OBJECTIVE MEANSOF DIAGNOSING GERD & MOTILITY DISORDERS1

EndoflipTM impedance planimetry system

BravoTM

calibration-free reflux testing system

Motility disorders often mimic symptoms of GERD, making diagnosis of esophageal symptomatic patients a challenge2

Esophageal symptomatic patient Negative endoscopy

Dysphagia

EndoflipTM impedance planimetry system

The system provides an internal view of the esophagus and the gastroesophageal junction during endoscopic and surgical procedures. It’s is a simple, well-tolerated test that will help you:7,8

∙ Measure pressure and dimensions of the esophagus and gastroesophageal junction

∙ Gain valuable insight — without fluoroscopy

∙ Identify or rule out major motility disorders

GERD

BravoTM calibration-free reflux testing system

Reflux (pH) testing is the gold standard for diagnosing GERD.9 This capsule-based patient-friendly reflux test measures acid levels in the esophagus.9,10

It has higher sensitivity than EGD and greater specificity than PPI trials, to help you obtain an objective diagnosis of GERD.1,11

Test for GERD at the time of a negative endoscopy without disrupting your workflow. With on-demand placement of the Bravo™ calibration-free reflux testing system, you can simply pair, place, and go.

Shared symptomsYou need an objective means of diagnosing GERD and motility disorders.

That’s why we offer two simple tests that can provide the therapeutic direction you’re looking for.

Tests aren’t conclusive. And treatment isn’t always effective.One in three patients referred with ongoing symptoms while using PPIs doesn’t have GERD.5 And PPI use has been associated with osteoporosis and other risks.6

Negative EndoflipTM helps to rule out motility disorders

BravoTM Confirm or rule out GERD

ManoScanTM Confirm and classify the motility disorderEndoflipTM

Food impaction

Heartburn

Chest pain

RegurgitationDysphagia

Positive EndoflipTM may indicate motility disorder

up to 50% of endoscopies for predominant esophageal symptoms are negative.3,4

US180386 © 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.

Endoflip™ impedance planimetry system:

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information: Similar to most procedures, the products featured here have inherent procedure risks associated. Please refer to the individual product user manuals for detailed information. Indication: The Endoflip™ system is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include:

To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

Contraindications: The Endoflip™ system is contraindicated where endoscopy is contraindicated. The Endoflip™ system is contraindicated for use in patients with actively bleeding varices in the esophagus.

Bravo™ calibration-free reflux testing system:

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Rx only.

Risk Information:

∙ The risks of Bravo™ calibration-free reflux testing system include: premature detachment, discomfort, failure to detach, failure to attach, capsule aspiration, capsule retention, tears in the mucosa, bleeding, and perforation

∙ Endoscopic placement may present additional risks

∙ Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur

∙ Because the capsule contains a small magnet, patients should not have an MRI study within 30 days of undergoing the Bravo™ pH test

Indications:

∙ The BravoTM monitoring system is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

∙ The BravoTM capsule can be attached following either endoscopy or manometry.

∙ The Reflux/Accuview software application is intended to record, store, view, and analyze gastroesophageal pH data.

Contraindications:

∙ Patients with bleeding diathesis, strictures, severe esophagitis, varices, or obstructions

∙ Patients with pacemakers or implantable cardiac defibrillators

References1. Hirano I, Zhang Q, Pandolfino JE, Kahrilas PJ. Four day Bravo pH capsule monitoring with and without proton pump inhibitor therapy. Clin

Gastroenterol & Hepatol. 2005;3(11):1083-8.

2. Chaudhury A, Mashimo H. Oropharyngeal & esophageal motility disorders. Current diagnosis & treatment: gastroenterology, hepatology and endoscopy. 3rd edition. 2016, chapter 13, page 164

3. Cassell, B., Sayuk, G. My approach to endoscopy - negative dysphagia. Gastroenterology. 2015 March 31, p.1.

4. ASGE Standards of Practice Committee, Muthusamy VR, Lightdale JR, Acosta RD et al. The role of endoscopy in the management of GERD. Gastrointest Endosc. 2015;81(6):1305-10.

5. Herregods, T. V. K., et al. Patients with refractory reflux symptoms often do not have GERD: Neurogastroenterology & Motility. 2015;27(9): 1267-1273.

6. Vakil N Prescribing proton pump inhibitors: is it time to pause and rethink? Drugs March 2012, Volume 72, (4), pp 437–445 72: 438.

7. Medtronic. Endoflip™ impedance planimetry system instructions for use (IFU). DD-41 Rev E. 2016.

8. Medtronic. Flip™ topography module instructions for use (IFU). DD-948 Rev A. 2017.

9. Sharma VK. The future is wireless: advances in wireless diagnostic and therapeutic technologies in gastroenterology. Gastroenterol. 2009:137(2):434-439.

10. Chitwood K. Perspectives on empiric and chronic proton pomp inhibitor therapy. Formulary. 2004:39(8):406-412.

11. Medtronic. Bravo™ reflux testing system instructions for use (IFU). DOC-4009-01. 2017.